Table 2. Summary of validation results

Property QC TAF TFV IS
Selectivity Analyte (% LLOQ) - 0.00 0.00
Internal standard (% IS) - 0.00 0.00
Carryover Analyte (% LLOQ) - 3.40 0.00
Internal standard (% IS) - 0.00 0.00 0.00
Linearity R square (R2) - 0.9982 0.9962
Intra-day accuracy and precision Accuracy (%) LLOQ 110.47 94.18
LQC 110.82 89.82
MQC 106.14 113.24
HQC 100.05 114.03
Precision, CV (%) LLOQ 7.55 9.60
LQC 2.94 5.89
MQC 2.25 2.00
HQC 4.69 1.00
Inter-day accuracy and precision Accuracy (%) LLOQ 114.51 100.07
LQC 104.97 87.74
MQC 101.84 101.82
HQC 97.11 108.28
Precision, CV (%) LLOQ 5.21 11.67
LQC 8.75 3.98
MQC 10.48 9.40
HQC 9.63 5.71
Matrix effect Precision, CV (%) LQC 9.57 13.32
HQC 6.10 2.90
Recovery Mean LQC 62.72 94.56 100.10
MQC 83.85 102.56 87.98
HQC 72.25 84.44 76.97
Precision, CV (%) LQC 5,39 6.75 4.21
MQC 2,72 3.62 1.79
HQC 4,31 3.45 2.58
Dilution integrity Accuracy (%) - 100.10 103.30
Precision, CV (%) - 1.69 4.08
Free-thaw stability % of nominal concentration LQC 105.64 91.12
HQC 102.36 111.97
At room temperature for 6 hours % of nominal concentration LQC 95.53 87.71
HQC 93.68 102.25
In autosampler for 24 hours at 10°C % of nominal concentration LQC 102.87 89.06
HQC 100.33 111.25
Long-term stability (after 60 days) % of nominal concentration LQC 101.80 92.79
HQC 105.95 95.00
Abbreviations: QC = quality control; LLOQ = lower limit of quantification; LQC = low level quality control; MQC = medium level quality control; HQC = high level quality control; IS = internal standard; CV = coefficient of variation